Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
United Therapeutics
Study ID
NCT04905693
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Idiopathic Pulmonary Fibrosis
  • Interstitial Lung Disease
  • Progressive Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inhaled Treprostinil — DRUG
    Inhaled Treprostinil (6 mcg/breath) administered QID
  • Treprostinil Ultrasonic Nebulizer — DEVICE
    Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.

Study Details

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.

Key Dates

First listed
May 28, 2021
Start date
Sep 6, 2022
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
1,850 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Inhaled Treprostinil
    Treprostinil inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled QID and titrated to a target of 15 breaths QID or until the subject reaches their maximum clinically tolerated dose.

Primary Outcome Measure

Long-term safety and tolerability of inhaled treprostinil in subjects with IPF or PPF [ Time Frame: Baseline to 6 years ]

Locations (86)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35233-
Clinical Trials Center of Middle TennesseeFranklinArizona37067-
Banner University Medical Center-PhoenixPhoenixArizona85006-
St. Joseph's Hospital and Medical Center - Norton Thoracic InstitutePhoenixArizona85013-
University of ArizonaTucsonArizona85724-
UC San Diego HealthLa JollaCalifornia92037-
David Geffen School of Medicine at UCLALos AngelesCalifornia90095-
NewportNativeMD, IncNewport BeachCalifornia92663-
Palmtree Clinical Research, Inc.Palm SpringsCalifornia92262-
UC Davis Health Medical CenterSacramentoCalifornia95817-
University of California San FranciscoSan FranciscoCalifornia94143-
Stanford University School of MedicineStanfordCalifornia94305-
National Jewish HealthDenverColorado80206-
University of Florida Health at ShandsGainesvilleFlorida32610-
Ascension St. Vincent'sJacksonvilleFlorida32204-
Mayo Clinic FloridaJacksonvilleFlorida32224-
University of FloridaJacksonvilleFlorida32209-
Pulmonary Disease Specialists, PA d/b/a PDS ResearchKissimmeeFlorida34741-
Central Florida Pulmonary Group, PAOrlandoFlorida32803-
Coastal Pulmonary & Critical Care PLCSt. PetersburgFlorida33704-
University of South Florida HealthTampaFlorida33606-
Cleveland Clinic FloridaWestonFlorida33331-
Emory UniversityAtlantaGeorgia30322-
Piedmont Healthcare AtlantaAtlantaGeorgia30309-
Northwestern Memorial HospitalChicagoIllinois60611-
Loyola University Medical CenterMaywoodIllinois60153-
Community Health NetworkIndianapolisIndiana46250-
University of Kansas Medical CenterKansas CityKansas66160-
Norton Pulmonary SpecialistsLouisvilleKentucky40202-
University of Louisville Healthcare Outpatient CenterLouisvilleKentucky40202-
Tulane University Medical CenterNew OrleansLouisiana70112-
LSU Health Science Center ShreveportShreveportLouisiana71103-
Johns Hopkins Asthma and Allergy CenterBaltimoreMaryland21224-
Adventist Healthcare White Oak Medical CenterSilver SpringMaryland98374-
Brigham and Women's HospitalBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Tufts Medical CenterBostonMassachusetts02111-
University of Michigan Int Med Pulmonary and critical careAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
Corewell Health William Beaumont HospitalRoyal OakMichigan48073-
University of MinnesotaMinneapolisMinnesota55455-
Mayo Clinic, Division of Pulmonary and Critical Care MedicineRochesterMinnesota55905-
University Mississippi Medical CenterJacksonMississippi39216-
The Lung Research Center, LLCChesterfieldMissouri63017-
Washington University School of MedicineSt LouisMissouri63110-
Creighton University Clinical Research OfficeOmahaNebraska68124-
University of New Mexico Health Sciences CenterAlbuquerqueNew Mexico87106-
Stony Brook Advanced Specialty CareCommackNew York11725-
Northwell HealthNew Hyde ParkNew York11042-
Weill Cornell Medical CenterNew YorkNew York10021-
University of Rochester Medical CenterRochesterNew York14642-
Montefiore Medical CenterThe BronxNew York10467-
Duke University Medical CenterDurhamNorth Carolina27710-
PulmonIx, LLCGreensboroNorth Carolina27403-
East Carolina UniversityGreenvilleNorth Carolina27834-
Southeastern Research CenterWinston-SalemNorth Carolina27103-
University of Cincinnati Medical CenterCincinnatiOhio45227-
Cleveland ClinicClevelandOhio44195-
The Ohio State University Wexner Medical CenterColumbusOhio43201-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
The Oregon ClinicPortlandOregon97220-
Penn State Milton S.Hershey Medical CenterHersheyPennsylvania17033-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Temple University HospitalPhiladelphiaPennsylvania19140-
Thomas Jefferson,Hospital UniversityPhiladelphiaPennsylvania19107-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Prisma Health MidlandsColumbiaSouth Carolina29203-
Clinical Research of Rock HillRock HillSouth Carolina29732-
StatCare Pulmonary Consultants, PLLCKnoxvilleTennessee37919-
Vanderbilt University Medical CenterNashvilleTennessee37204-
Baylor University Medical CenterDallasTexas75246-
University of Texas Southwestern Medical CenterDallasTexas75390-8550-
Baylor College of MedicineHoustonTexas77030-
Houston MethodistHoustonTexas77030-
The University of Texas Health Science Center at HoustonHoustonTexas77030-
The University of Texas Health Science Center at Houston, McGovern Medical SchoolHoustonTexas77030-
A & A Research Consultants, LLCMcAllenTexas78503-
Metroplex Pulmonary and Sleep Center PAMcKinneyTexas75069-
Renovatio ClinicalThe WoodlandsTexas77380-
Intermountain HealthcareMurrayUtah84107-
University of Utah HealthSalt Lake CityUtah84108-
University of Virginia Health SystemsCharlottesvilleVirginia22903-
Inova Fairfax HospitalFalls ChurchVirginia22042-
Pulmonary Associates of Richmond, Inc.RichmondVirginia23230-
University Hospital and UW Health ClinicsMadisonWisconsin53792-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
The University of Alabama at Birmingham· Birmingham, ALClinical Trials Center of Middle Tennessee· Franklin, AZBanner University Medical Center-Phoenix· Phoenix, AZSt. Joseph's Hospital and Medical Center - Norton Thoracic Institute· Phoenix, AZUniversity of Arizona· Tucson, AZUC San Diego Health· La Jolla, CA

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